OP55 Classification System For Innovative Medicines In The Pipeline: New Or Repurposed?

Abstract

Introduction

While various criteria exist to define or categorize innovative medicines as new or repurposed, to our knowledge there are no standardized systems that sufficiently capture the range of pipeline products. The National Institute for Health and Care Research Innovation Observatory (NIHR IO) undertakes routine horizon scanning to support health technology assessment (HTA) in England and maintains a comprehensive Medicines Innovation Database (MInD). The aim of this project is to develop a ‘technology type’ (new versus repurposed) classification system for application within the MInD and to provide a high-level analysis of the emergent data.

Methods

We reviewed gray literature, regulatory websites, and drug repositories to identify existing ‘technology type’ classification criteria. Preliminary definitions and classifications for use on the MInD were discussed, refined, and agreed by consensus. Innovative medicines on the MInD were classified as either new or repurposed based on their regulatory approval status (Marketing Authorization) using data from the electronic medicines compendium. For repurposed medicines, further classification was undertaken using abbreviated new drug application (ANDA) data from the FDA Orange Book to identify generic medicines (patency and exclusivity status). We combined a range of semi-automated and manually derived data during this process.

Results

Six technology types were identified and applied to the MInD: (i) new technology; (ii) repurposed technology (on-patent/branded); (iii) repurposed drug (off-patent/generic); (iv) repurposed technology (never commercialized); (v) new and repurposed technology (combinations); and (vi) repurposed technology (combinations). Preliminary analysis of a subset of MInD records identified in July 2021 (n = 113) found mainly 52 percent new technologies, 27 percent new and repurposed technologies (combinations) and 14 percent repurposed technology (never commercialized). Further analysis of approximately 7000 MInD records are ongoing and will report temporal trends, regulatory status, and key challenges.

Conclusions

Our novel evidence-based approach to developing classifications for technology types of innovative medicines resulted in six mutually exclusive states that can be applied to a larger dataset. We believe this offers HTA stakeholders a mechanism to gain valuable insights into the innovation trends, gaps, and areas of unmet need.